Ensure EU regulatory compliance through the Person Responsible for Regulatory Compliance (PRRC)
The Person Responsible for Regulatory Compliance (PRRC) is a new requirement of the European regulation EU 2017/745 on medical devices (MDR). The regulation requires that companies distributing medical devices in EU markets employ a dedicated PRRC at both the manufacturer and authorized representative sites. The manufacturer’s PRRC must be an in-house employee except in the case of small or micro companies in which case the PRRC role may be outsourced. The PRRC must meet required qualifications and must be permanently and continuously at the company’s disposal.
The PRRC ensures that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. The PRRC tasks include:
- Ensuring technical documentation is drawn up and kept up-to-date;
- Ensuring the EU Declaration of Conformity is drawn up and kept up-to-date;
- Ensuring compliance with post-market surveillance obligations;
- Ensuring reporting obligations are fulfilled
In compliance with the MDR, companies must ensure that the PRRC suffer no disadvantage within the organization and are furnished with applicable resources in relation to the proper fulfillment of duties
How can we help?
Li-Med’s regulatory and quality assurance expertise and experience allow us to offer our services as an outsourced PRRC for micro and small companies or train your internal PRRC in your organization. Given the necessary authority, accessibility, and other required resources, companies may capitalize on our long-standing and proven track record in successfully designing, applying, and internally auditing the various aspects of regulatory affairs governing medical devices in general and those marketed in the EU in particular.